WHEN IS DISCLOSURE NOT DISCLOSURE?

WHEN IS DISCLOSURE NOT DISCLOSURE?

Hint: When it is made by the Chairman of the DSM-5 Task Force.

Here is a case study in conflict of interest (COI). A remarkable confession has just appeared by a group of 5 prominent academics, writing in the journal JAMA Psychiatry. Having been outed to the Editors, they now admit to concealing pertinent financial information. One of the five is David J. Kupfer, MD, chairman of the DSM-5 Task Force and past chairman of the department of psychiatry at The University of Pittsburgh. The others are from Pittsburgh, Minnesota, and Chicago.

With millions in funding from NIMH, these folks have been developing new approaches to testing for anxiety and depression. The technical details are not important for this story. What matters is that they have clearly set their sights on a large market for diagnostic screening, epidemiological research, and clinical practice. They have recently published promotional reports talking up three products and projecting major applications – but before taking care of the nuts and bolts of scale development.

Their major report in JAMA Psychiatry contained a disclosure to the effect that they might at some time in the future consider commercial development of their depression scale. This disclosure was phony. We now know that, in lieu of frankly disclosing a major COI, they opted for a disingenuous, dissembling statement that was economical with the truth.

I thought the content of their report was sub-par, and the journal published a letter from me to that effect. They responded to my criticism with hand waving, and they tried to impugn me for bias related to my own (disclosed) COI. This foolish, ad hominem tactic aimed to divert attention from the substance of my critique – for which they had no adequate response.

As I am not a person who suffers fools or insults gladly, their evasive response caused me to do some checking. I quickly learned that the gang of five are shareholders in a private corporation. Before their paper was accepted by JAMA Psychiatry, the corporation was incorporated in Delaware and soon after registered to do business in Illinois. Those facts were not disclosed in the original report or in the published letter of Reply to me. These omissions were acknowledged in the notice of Failure to Report that appeared on-line today.

It gets worse. Other things that I learned – and that I communicated to the journal – make it clear that the corporate train had left the station in advance of the letter of Reply. For instance, a professional operations and management executive (Mr. Yehuda Cohen) had joined the corporation. He had established the corporate website, where he was featured as a principal, along with the gang of five. The website also displayed a professionally crafted Privacy Policy, dated ahead of the letter of Reply. This document identified what appears to be a commercial business address for the corporation. The notice of Failure to Disclose is silent on these facts.

So, the published notice of Failure to Disclose still withholds pertinent information, which makes a mockery of the weasel words that they have not released any tests for commercial or professional use. Not yet, they haven’t. But they are under way, make no mistake. This prevarication creates the impression of a habitual lack of transparency. Considering that I gave the journal all this information, one has to be surprised that JAMA Psychiatry went along with this prevarication. Plus, would it have killed them to apologize for their foolish attempt to smear me, as I requested? In correspondence with me, the Editor in Chief of JAMA didn’t want to go there, and he refused to publish my letter that detailed the facts, citing the most specious of grounds. The Editor of JAMA Psychiatry has ducked for cover when I faulted him for publishing the ad hominem material in the first place.

This deplorable episode casts a pall on the repeated assurances by Dr. Kupfer that COI issues were under control in the DSM-5 process. If the chairman of the DSM-5 Task Force doesn’t have his own act together, then what are his assurances worth? The new instruments proposed by this corporation bear an eerie resemblance to cross-cutting dimensional measures that were promoted for DSM-5 but that didn’t make the final cut. As far as I know, Dr. Kupfer didn’t declare his interest in this corporation for scrutiny vis à vis DSM-5.

Another lesson is that even Failure to Report notices can be weasel documents. I fault the Editors of JAMA Psychiatry, Joseph Coyle, MD, and of JAMA, Howard Bauchner, MD, for the non-rigorous standard they applied to the notice of Failure to Disclose. They acquiesced in another dissembling response.

Yet another lesson is that all authors are accountable for the accuracy of disclosure statements. Some of these authors might claim they relied on the lead author and president of the corporation, Robert Gibbons, PhD, a statistician at The University of Chicago, to make sure everything was kosher. Big mistake – just like the infamous case of the Nemeroff-led Cyberonics – vagus nerve stimulation review that failed to disclose that the academic authors (ahem) were paid consultants of the corporation. When your name is on the byline, be sure you cover the bases for your own protection, and don’t squawk when you are called out.

Finally, where is NIMH in all of this? Since when are public NIMH funds to be treated as commercial seed money? Who actually owns the algorithms and data bases on which the Gibbons corporation relies for its commercial aspirations? Why are they not publicly accessible? Is Thomas Insel on top of this?

JAMA: "Improving the Electronic Health Record—Are Clinicians Getting What They Wished For?" - No, But Utopia Arrives Soon

At a new JAMA piece "Improving the Electronic Health Record—Are Clinicians Getting What They Wished For?", former Columbia U. and now NIH medical informaticist James J. Cimino, MD points out issues with the documentation that results from health IT systems.

A preview of the first page of this short Viewpoint piece is available free at this link.  It includes the observation that:

... There is no question that computerization has made patients’ records more available and legible. With respect to completeness, however, there are now complaints that the record is too complete: electronic notes are deemed by many clinicians as being full of extraneous details and obscuring important aspects of a patient’s condition

Dr. Cimino goes on to state that:

Empirical observational studies of clinicians have shown ways to improve EHR functionality ... Similar research on clinical documentation processes is needed to advance this crucial EHR component.

These are excellent observations.

The issue I have with the piece is - and I am finding this true of many articles critical of today's health IT - the ending, which I'm finding to often be PR.  Or, perhaps it would be more accurate to call the endings of late a "salvage operation-style" attempt to save face for the informatics community, who let this domain be overrun by the corporate IT sector and terrible products that violate many of the precepts of design of good health IT learned during five decades of research.

Cimino concludes an otherwise constructive piece with this statement:

... Rather than complain about the challenges [a euphemism if ever I saw one - ed.] they have introduced, clinicians should recognize that current EHRs are illuminating the opportunities for the next generation of systems that will support clinicians as active partners across the spectrum of health care settings and tasks. The resulting improvements in documentation will, in turn, support patients, administrators, and researchers as we move towards a true learning health system.

I note this assertion is at complete odds with the dictum I was taught from my earliest medical mentors, and that no amount of wishful thinking will banish:

"Critical thinking always, or your patient's dead." (Cardiothoracic surgery pioneer Victor P. Satinsly, M.D., Hahnemann Medical College, Philadelphia, early 1970s.)

Translating the statement into plainer English, it seems to me that Cimino is saying this:

"Doctors, shut up, stop complaining about the chaos and patient/professional risk today's bad health IT is causing, take the medicine your betters have prescribed for you, and don't be uncompromising patient advocates as patients are secondary in this quest to reach IT-based Healthcare Utopia - which we will reach come version 2.0."

(This comes, ironically, at a time when physicians are starting to get a voice, e.g., Twitter's #EHRbacklash.)

It appears articles with even a faint tinge of anti-health IT sentiment - in addition to the traditional methods, results, limitations etc. sections - have an "appeasement" section as well.  Perhaps this it what it takes to get past peer review and/or industry ire.

In my view, this salvage mentality sprinkled with euphemisms and Utopian rhetoric spoils an otherwise constructive piece.  This type of language and utopian predictions about HIT have also appeared in other major medical publications by informatics and healthcare leaders (including top governmental office holders), as for example here.

Now, I know Jim Cimino and he is a good scientist.  However, I truly wish the non-scientific, "wait for version 2.0", utopian P.R. would stop.  As a member of the Medical Informatics profession myself, it's actually become embarrassing.

-- SS